Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
NCT ID: NCT03211247
Last Updated: 2024-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
414 participants
INTERVENTIONAL
2017-07-31
2022-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
* In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A Viaskin Peanut 250 mcg
Part A Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
Part A Viaskin Peanut 100 mcg
Part A Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily
Part A Placebo
Part A Placebo
Placebo patch, once daily
Part B Viaskin Peanut 250 mcg
Part B Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
Part B Placebo
Part B Placebo
Placebo patch, once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Part A Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
Part A Viaskin Peanut 100 mcg
Viaskin Peanut 100 mcg, once daily
Part A Placebo
Placebo patch, once daily
Part B Viaskin Peanut 250 mcg
Viaskin Peanut 250 mcg, once daily
Part B Placebo
Placebo patch, once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Physician-diagnosed peanut allergy;
* Peanut-specific IgE level \> 0.7 kU/L;
* Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
* Positive DBPCFC at ≤ 300 mg peanut protein;
Exclusion Criteria
* History of severe anaphylaxis to peanut;
* Prior immunotherapy to any food or other immunotherapy;
* Generalized severe dermatologic disease;
1 Year
3 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
DBV Technologies
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Arizona Health Science
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California School of Medicine
Los Angeles, California, United States
University of California, Rady Children's Hospital
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University School of Medicine
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's national Health System
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
Chicago, Illinois, United States
The Universal of Chicago Medical Center
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Childrens' Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
The University of North Carolina - Chapell Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States
ASTHMA, Inc.
Seattle, Washington, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Sydney Children's Hospital
Randwick, NWS, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
The Women's and children's hospital
North Adelaide, South Australia, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
CHUM & CHU Sainte-Justine
Montreal, Quebec, Canada
CHRU Lille
Lille, , France
CHRU Metz-Thionville
Metz, , France
Hopitaux Pediatriques de Nice
Nice, , France
Hopital Necker
Paris, , France
CHRU Nancy
Vandœuvre-lès-Nancy, , France
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Universitatklinikum Giessen und Marburg
Marburg, , Germany
Cork University Hospital
Cork, , Ireland
Erasmus MC Sophia Children's Hospital
Rotterdam, , Netherlands
Guy's and Saint Thomas' NHS Foundation Trust
London, , United Kingdom
St.Mary's Hospital
London, , United Kingdom
ROyal Manchester Children's Hospital
Manchester, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Scurlock AM, Fleischer DM, Toit GD, Arends NJT, Pongracic JA, Trujillo J, Turner P, Vogelberg C, Bee KJ, Green TD, Meney J, Bois T, Campbell DE, Sampson HA, Burks AW. Efficacy and safety of epicutaneous immunotherapy in children with peanut allergy with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Aug;135(2):203-210. doi: 10.1016/j.anai.2025.04.002. Epub 2025 Apr 7.
Greenhawt M, Sindher SB, Wang J, O'Sullivan M, du Toit G, Kim EH, Albright D, Anvari S, Arends N, Arkwright PD, Begin P, Blumchen K, Bourrier T, Brown-Whitehorn T, Cassell H, Chan ES, Ciaccio CE, Deschildre A, Divaret-Chauveau A, Dorris SL, Dorsey MJ, Eiwegger T, Erlewyn-Lajeunesse M, Fleischer DM, Ford LS, Garcia-Lloret M, Giovannini-Chami L, Hourihane JO, Jay N, Jones SM, Kerns LA, Kloepfer KM, Leonard S, Lezmi G, Lieberman JA, Lomas J, Makhija M, Parrish C, Peake J, Perrett KP, Petroni D, Pfutzner W, Pongracic JA, Quinn P, Robison RG, Sanders G, Schneider L, Sharma HP, Trujillo J, Turner PJ, Tuttle K, Upton JE, Varshney P, Vickery BP, Vogelberg C, Wainstein B, Wood RA, Bee KJ, Campbell DE, Green TD, Rouissi R, Peillon A, Bahnson HT, Bois T, Sampson HA, Burks AW. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. N Engl J Med. 2023 May 11;388(19):1755-1766. doi: 10.1056/NEJMoa2212895.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPITOPE
Identifier Type: -
Identifier Source: org_study_id